Kiromic BioPharma Reports Tumor Volume Decrease in Two Patients Enrolled in Deltacel-01
Provides Enrollment Update for Phase 1 Study in Late-Stage Non-small Cell Lung Cancer
Kiromic BioPharma, Inc. (OTCQB:KRBP) ("Kiromic" or the "Company") reports favorable efficacy results from the 12-month follow-up visit for the first patient and the two-month follow-up visit for the seventh patient enrolled in its Deltacel-01 Phase 1 clinical trial, and provides an enrollment update. This trial is evaluating Deltacel™ (KB-GDT-01), the Company's allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic or locally-advanced non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.
At the 12-month post-treatment follow-up visit, the first patient in Deltacel-01 had a 33.33% reduction in tumor volume compared with their pre-treatment tumor size, thereby achieving a partial response. This marks the second patient in the Deltacel-01 study with a partial response after our fourth patient. Additionally, the seventh patient had a 9.5% reduction in tumor size at their two-month follow-up visit. Both patients are being treated at the Beverly Hills Cancer Center (BHCC).
"The sustained, positive results we are seeing with the Deltacel-01 clinical trial are highly encouraging. Having a second patient achieve partial response with the first patient's remarkable 33% tumor shrinkage at the 12-month follow-up highlights the therapeutic potential of our gamma-delta T cell therapy. The early response observed in the seventh patient further supports our confidence in this platform. We are expanding trial enrollment to expose more patients to the potential benefit of Deltacel while bolstering our clinical dataset," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.
"The remarkable 33% tumor reduction seen in the first and fourth patient at our center along with the encouraging 9.5% reduction in the seventh patient, are truly exciting results from the Deltacel-01 clinical trial. These data, coupled with the patients' reports of improved energy and better quality of life, reinforce the potential of Kiromic's gamma delta T-cell therapy to deliver meaningful clinical benefit for patients with advanced lung cancer who have exhausted other treatment options," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at BHCC. "As a leading cancer center focused on providing access to the most innovative therapies, we are proud to partner with Kiromic and look forward to continuing to enroll patients and generate additional evidence supporting Deltacel's promise as a transformative new treatment option."
The Eighth Patient Completes Treatment
The eighth patient successfully completed the Deltacel-01 treatment regimen and is tolerating therapy well. Initial efficacy results for this patient are expected in late February 2025. This patient was enrolled at the Clinical Research Advisors Koreatown, a satellite location of BHCC.
Kiromic also announces that the ninth patient in Deltacel-01 started treatment at Virginia Oncology Associates (Norfolk, VA). Additionally, the company expects to enroll the 10th and 11th patients into the trial by the end of January.
About Deltacel-01
In Kiromic's open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with advanced NSCLC receive three intravenous infusions of Deltacel™ with six courses of low-dose, localized radiation over a 31-day period. The primary objective of Deltacel-01 is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.
About Deltacel™
Deltacel™ (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel™ is the leading candidate in Kiromic's GDT platform. Deltacel™ is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel™'s favorable safety and efficacy profile when it was combined with low-dose radiation.
About the Beverly Hills Cancer Center
As a private, academic, community-based cancer center, the Beverly Hills Cancer Center not only provides the latest state-of-the-art cancer treatments all under one roof, but also provides leading clinical trials and research, attracting patients globally. By providing access to groundbreaking clinical trials, the Beverly Hills Cancer Center offers patients the opportunity to participate in the most advanced cancer treatments currently in development in the world. Beverly Hills Cancer Center is comprised of an internationally recognized multidisciplinary medical team consisting of medical oncologists, radiation oncologists, radiologists, hematologists and internists who provide exceptional patient care and support services including a robust and highly efficient team of clinical research professionals. More information is available at www.BHCancerCenter.com.
About Clinical Research Advisors LLC
Founded in 2022 by current researchers and technology entrepreneurs at Beverly Hills Cancer Center, Clinical Research Advisors is a first-of-its-kind clinical trial optimization company harnessing the power of AI and real-world data capitalizing on the decade success of the high-quality clinical trial program developed at its main site, Beverly Hills Cancer Center, established over 15 years ago. Having a central site makes us different than other site networks. We strive to accelerate the development of new treatments and cures by addressing major roadblocks in patient recruitment and site activation. By leveraging our central site, Beverly Hills Cancer Center, integrated network of growing satellite sites and advanced technologies, we aim to make clinical research participation more accessible and efficient. More information is available at www.ClinicalResearchAdvisors.com
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic is using its proprietary DIAMOND® artificial intelligence (AI) 2.0 platform to discover novel targets for immuno-oncology. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromic's ability to achieve its objectives and Kiromic's financing strategy and availability of funds. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended December 31, 2023, and as detailed from time to time in our other SEC filings. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Such forward-looking statements relate only to events as of the date of this press release. We undertake no obligation to update any forward-looking statements except to the extent required by law.
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Alliance Advisors IR
Tirth T. Patel
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212-201-6614
Beverly Hills Cancer Center
Sharon Neman, MBA
Chief Strategy Officer
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310-432-8925
Clinical Research Advisors LLC
Ali Muhammad, MD, MBA
Co-Founder & Director of Clinical Research Operations
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310-432-8934